Recall Z-1641-2015 ยท GDW Staple, Implantable
Ethicon Endo-Surgery Inc
ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
| Date | May 21, 2015 (initiated Feb 26, 2015) |
| Status | Terminated |
| Reason | During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line. |
| Root cause | Software in the Use Environment |
| Action | Ethicon sent an Urgent Medical Device Recall letter dated February 27, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine your inventory immediately to determine if you have recalled product on hand, remove and quarantine the recalled product, communicate the issue to relevant operating room or materials management personnel or anyone else in your facility who needs to be informed, if any product included in this recall has been forwarded to another facility, contact that facility to arrange return, and c |
| Quantity | 6,744 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141952 | ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED Ethicon Endo-Surgery, Inc., Nov 24, 2014 |